title: Seasonal influenza vaccine delivered by intradermal microinjection: A randomised controlled safety and immunogenicity trial in adults.
abstract: Influenza vaccines remain largely underused. A promising alternative to current intramuscular vaccines is a trivalent inactivated influenza vaccine (TIV) delivered using a microinjection system to offer a less invasive and possibly more acceptable vaccination. A phase II, multicentre, randomised open-label study in 978 healthy adults (18-57 years) evaluated the immunogenicity and safety of intradermal TIV. Subjects received a 0.1 ml injection of intradermal TIV, containing 9 microg of haemagglutinin (HA) per strain (n = 588) or a conventional 0.5 ml intramuscular vaccine (15 microg of HA/strain; n = 390). Intradermal TIV induced non-inferior humoral immune responses against all three strains and superior responses against both A strains (H1N1, H3N2) compared with the control. Both vaccines were well tolerated.
authors.affiliation: Center for Vaccinology, Ghent University and Hospital, De Pintelaan 185, 9000 Ghent, Belgium. Isabel.LerouxRoels@UGent.be
authors.forename: Isabel
authors.initials: I
authors.lastname: Leroux-Roels
authors.forename: Eva
authors.initials: E
authors.lastname: Vets
authors.forename: Ralf
authors.initials: R
authors.lastname: Freese
authors.forename: Michael
authors.initials: M
authors.lastname: Seiberling
authors.forename: Françoise
authors.initials: F
authors.lastname: Weber
authors.forename: Camille
authors.initials: C
authors.lastname: Salamand
authors.forename: Geert
authors.initials: G
authors.lastname: Leroux-Roels
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000276:immunology; D005260:Female; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000276:immunology; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D007271:Injections, Intradermal; D008297:Male; D008845:Microinjections; D008875:Middle Aged; D014611:Vaccination; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated; C478242:vaxigrip